Type 1 DiabetesNCT06516614
Sleep Coach for Adolescents With Type 1 Diabetes
A study testing Sleep Coach and Diabetes Education in people with Type 1 Diabetes, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
The goal of this work is to conduct a randomized trial evaluating the effects of a behavioral intervention to increase sleep duration and quality for adolescents with type 1 diabetes (T1D). The impact of the sleep-promoting intervention on executive function and glycemic outcomes will be assessed. Read more about this study
- Who is it for?
- Ages 11 to 17 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Sleep Coach and Diabetes Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Sep 2024to Sep 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 11-17 years of age at the time of enrollment
- Diagnosed with type 1 diabetes for ≥ 12 months
- Report insufficient sleep (< 8 hrs./night for 13-17 year-olds, <9 hrs./night for 11-12 year-olds) but have no other sleep disorders or sleep apnea
- Are not meeting the target for HbA1c (<7%)
- Able to read /speak English
- Currently living with the child (at least 50% of the time)
- Speak and read English
Who cannot join
- Participant has other serious health conditions that interfere with diabetes management
- Optional MRI portion of the study - anything that would prevent an adolescent from receiving a high-quality MRI of the brain (metal implants or inability to hold still for an MRI which may take up to 60 minutes)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37212
Lauren Milner, MPH, lauren.l.milner@vumc.org
About this study
Official title: Sleep Promoting Intervention to Improve Diabetes Outcomes and Executive Function in Adolescents With T1D
The goal of this work is to conduct a randomized trial evaluating the effects of a behavioral intervention to increase sleep duration and quality for adolescents with type 1 diabetes (T1D). The impact of the sleep-promoting intervention on executive function and glycemic outcomes will be assessed. We will also explore multiple components of the recently identified central nervous system glymphatic system and evaluate how these components change and impact brain integrity and function with improved sleep.
Read the detailed description
This randomized controlled trial will assess whether a behavioral coaching intervention to improve sleep duration and quality in adolescents with type 1 diabetes will improve glucose control and executive function. We will recruit a sample of 150 adolescents with type 1 diabetes (T1D) and their caregivers at a single medical center. We plan to recruit equal numbers of boys and girls and over-enroll youth from minoritized racial and ethnic groups. After obtaining informed consent/assent and baseline data, we will randomize adolescents to the Sleep Coach condition (n=75) or the Enhanced Usual Care condition (n=75). Randomization will be computerized, and adolescents will be stratified by diabetes device use (insulin pumps, continuous glucose monitors) and age (11-14 years vs. 15-17 years). Adolescents and caregivers will complete survey measures again at 3 months, 6 months, and 12 months during regularly scheduled clinic visits. Adolescents will complete the NIH Toolbox measures of executive function at each study visit. Adolescents will be asked to wear a FitBit watch to assess sleep and complete sleep diaries at baseline and 3 months.
Participants randomized to the Sleep Coach group will be sent a binder with intervention materials for the 4 sessions. They will schedule individual phone calls with a trained member of the research team at a convenient time. The first call is expected to last 20-30 minutes, and the other calls are expected to last 10-15 minutes. Caregivers will receive an overview of the sleep intervention content, and they will be asked to support adolescents' attempts to change sleep habits.
Adolescents randomized to Enhanced Usual Care will receive diabetes education materials developed by our team for adolescents with T1D (based on publicly available materials on diabetes.org). Printed materials will be sent via mail and content will be shared via smart phone messages on the same schedule as participants randomized to the Sleep Coach intervention.
A representative group of 50 of the 150 adolescents in the study will be invited to participate in an additional study visit prior to the intervention to obtain magnetic resonance imaging (MRI) of the brain. Adolescents who agree to complete MRI of the brain will be asked to complete a follow-up visit approximately 6 months after the baseline visit, following the same protocol, and they will complete the daily sleep diary questions and share sleep data for another week.
- Conditions
- Type 1 Diabetes
- Being tested
- Sleep Coach, Diabetes Education
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep CoachBehavioural
Sleep-promoting intervention consisting of 4 phone sessions to improve sleep duration and consistency.
Diabetes EducationBehavioural
Participants will receive a a binder with educational information about diabetes and educational messages from the study team.
| Study group | Role | What they receive |
|---|---|---|
| Sleep-Promoting Intervention | Experimental | Individualized sleep-promoting program for adolescents with type 1 diabetes Receives: Behavioral: Sleep Coach |
| Enhanced Usual Care | Active comparator | Educational Materials Receives: Behavioral: Diabetes Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep Duration
Total Sleep Time (average minutes per night) measured with Fitbit over 7 nights
Measured: 3 months
Sleep Variability
Individual difference in sleep duration (minutes) measured with Fitbit over 7 nights
Measured: 3 months
Secondary outcomes (10)
Executive Function BRIEF2
Behavior Rating Inventory of Executive Function 2nd Edition: 63-item measure, completed by parents to assess adolescent executive function in their daily life. Higher Global Executive Composite score indicates better executive function.
Measured: 12 months
NIH Toolbox Dimensional Card Sort Test
Dimensional Change Card Sort Test takes 4 minutes for adolescents to complete on an iPad, assesses inhibition, a component of executive function
Measured: 12 months
NIH Toolbox List Sorting Working Memory Test
List Sorting Working Memory takes 8-10 minutes for adolescents to complete on an iPad, assesses working memory, a component of executive function
Measured: 12 months
Diabetes Management - Adolescent Report
Self-Care Inventory-Short Form: 9-item measure, assesses key components of adolescent diabetes management. Higher mean scores indicate better diabetes self-care.
Measured: 12 months
Diabetes Management - Parent Report
Self-Care Inventory-Short Form: 9-item measure, assesses key components of adolescent diabetes management. Higher mean scores indicate better diabetes self-care.
Measured: 12 months
Sleep Quality
Pittsburgh Sleep Quality Index (PSQI): 21-item measure completed by adolescents, assesses sleep quality. Higher scores indicate poorer sleep quality.
Measured: 12 months
Hemoglobin A1C
An indicator of average blood glucose levels. HbA1c is collected as part of usual care and will be extracted from adolescents' medical records
Measured: 12 months
Time in Range
Blood glucose levels, measured with continuous glucose monitors, that are within the target range (70-180 mg/dL) over 14 days. Time in Range is reported as a percentage and higher levels indicate better glycemic control.
Measured: 12 months
Magnetic Resonance Imaging (MRI) of Brain: Glymphatic Flow
Fluid motion along perivascular spaces is assessed from MRI of the brian
Measured: 6 months
Fractional Anisotropy from MRI of the Brain
Fractional anisotropy is calculated from diffusion tensor imaging MRI. Higher FA is associated with better white matter integrity in the brain
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2024
- Study start18 Sep 2024
- Primary completionSep 2027 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarah Jaser, Vanderbilt University Medical Center
- Investigators
- Sarah Jaser, PhD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06516614
- Sponsor's protocol ID
- 230074
- Status last verified
- Oct 2026
- First submitted
- 17 Jul 2024
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No